The U.S. Food and Drug Administration (FDA) has expanded the approved indications for use and labeling of Cerapedics Inc.’s peptide enhanced bone graft, iFactor.
According to Cerapedics, iFactor is now approved for “single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation.”
At this time, the bone graft can be used with “most interbody cages on the market providing proven safety and fusion efficacy through human clinical data.”
The bone graft, iFACTOR P-15 Peptide Enhanced Bone Graft, is a Class III FDA approved bone graft and, according to Cerapedics, is the “only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, with a precise bone-building mechanism.” The bone graft is indicated for use in “skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7.”
Cerapedics Inc. is a global leader in advanced bone graft technology and the only one of two companies with a PMA approved bone graft adjunct to spine fusion surgery. iFactor P-15 has one of the most extensive libraries of published peer reviewed studies that document iFactor P-15’s ability to safely and effectively augment bone growth for spine fusion cases.
Cerapedics CEO Valeska Schroeder commented, “This label expansion approval is part of our deep commitment to bring scientific rigor to bone grafting so surgeons and the patients they treat have access to products with proven safety, efficacy and evidence.”
Schroeder continued, “i-FACTOR has been a trusted choice in bone graft selection in the United States since 2015 as the only bone graft replacement FDA-approved for single-level ACDF procedures with a premarket approval based on a Level 1 human clinical trial. We are proud to have FDA approval for the safe and effective use of i-FACTOR in PEEK and titanium cages.”
